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					Ethical evaluation




      Timo Nevalainen
 University of Eastern Finland
           Ethics?

to do good
not to do bad




                 Is it worth it?
                 Does it hurt?
             Interests groups

Abolition                     No restrictions




                 Scientists




Animal welfare                Patient groups
Tools for assessment?

 Science community
    well meaning ethical purpose
    how to balance purpose with cost
 Philosophies
    animal rights, utilitarism
    at project level of little help
 Law
Law, science & ethics
     Harmonization




                     excellence
Council of Europe (CoE)
Convention

   Revision of Appendix A
      CoE working groups
      species specific documents
         general, rodents, rabbit, dogs, cats, primates,
         fish and farm animals
      enrichment and group housing
         mandatory unless there is a veterinary or
         scientific reason not to
    European Science Foundation


Use of Animals in Research (2001)
 ..animal use should be subjected to independent
  expert review
 .. both scientific and animal welfare considerations

 .. weighing of the likely benefit and likely animal

  suffering …an essential part of the review process
www.esf.org
    Report on Directive 86/609 … s
           (2001/2259(INI))
                                by
  Committee on the Environment, Public Health and Consumer Policy



must be able clearly to substantiate and
 justify the purpose … the experiments will be
 of benefit to animals or humans
an ethical and animal-welfare assessment
 must be carried setting limits to the level of
 stress to which the animals may be subjected
should include a cost/benefit analysis
Revision of the Directive

    Experts meet in Brussels
    Four groups
     Scope, the 3Rs, Central Database
     Authorisation
     Ethical review
     Cost-benefit analysis and severity
      classification
           Cost-benefit




                          Cost
                          Cost
Benefit
 Benefit
 Can a proper cost-benefit
   analysis be made?

 A cost-benefit analysis = An ethical
judgement
Basis: weight suffering of the
experimental animals against
fulfilling human needs
Why is Cost-Benefit difficult?


 1.   Different scientific viewpoints
 2.   Conflicting daily experiences
 3.   Different (moral) viewpoints
 4.   Considerable political charge
                 Practical Ethics

Ethics Committees
   Do we have to know ?
      basic research
      applied research
   Project review
      cost-benefit analysis
      probability to get valid,
      reliable results
Breakdown of costs and benefits


Both should be assessed
Relative weight of elements?
How to use?
   Scoring systems



   Identification of problem areas
   Item(s) to be improved
   Thought assistance
          Porter’s scoring
A. Purpose of study    Scoring 1-5
B. Probability for     Points C-H
reaching the purpose      max 30
C. Species                limit 15
D. Anticipated pain    Points A-H
E. Duration of pain       max 40
F. Duration of exp        limit 22

G. Number of animals   Ref: Nature 356:
                       101-102, 1992
H. Animal care
     Porter / Research

A. Aim of the experiment
   1 = alleviation of substantial human ior animal
    pain
   3 = clear benefit to human or non-human health
    or welfare
   5 = advancement of knowledge
B. Realistic potential to achieve goals
   1 = excellent
   5 = very limited or cannot be assessed
       Porter / Animals I


C. Species
   5 = NHP, 4 = other mammals….
D. Likely pain
   5 = Severe..1 = None
E. Duration of pain
   5 = very long..1 = none or very short
              Porter / Animals II

F. Duration of experiment           G. Number of animals
   in relation to life span (LS)      5 =>100
   5 = > 0.2 x LS                     4 = 20-100
       (mouse – 110 days)              3 = 10-20
   4 = 0.02 x LS                      2 = 5-10
   3 = 0.002 x LS                     1 = 1-5
   2 = 0.0002 x LS                    or lowest score for
   1 = 0.00001 x LS                    appropriate no of
       (mouse – 10 min)                 animals?
    An example of possible cost
Quality of animal care (New App A)
   Excellent
       space above minimum / group housing / enrichment / bedding
   Very good
       one of the criteria above missing
   Good
       two of the criteria above missing
   Satisfactory
       three of the criteria above missing
   Poor
       minimum space, alone and no enrichment
        Concluding Remarks
Unfair for fundamental research ?
   57 Nobel prizes in medicine
Problems with GM-animals ?
   life time studies, high number of animals
Expects major advances with minor cost
   yet, ideal worth thriving for
Limits set too low?
Breakdown clarifies thinking
   Example:
Xylitol and dogs

Man                           Dogs
   commonly used                2-year toxicity study at
    sweetener                     2 g/kg daily in diet
   positive effects on           resulted in minor liver
    caries and on ear             changes
    infections                   accidental consumption
   excessive use may             of xylitol: mortality with
    induce laxative effects       seizures clinically
Formulating hypothesis


 Kuzuya et al. 1966: Xylitol in dogs produces
 much stronger insulin release than glucose
 Hypothesis: Ingested xylitol causes insulin
 secretion, which results in hypoglycemia
 BUT: Was this tested in the 2-year toxicity
 study ?
 Hypoglycemia only in fasted dogs ?
 What about home-made first aid ?
     Scoring xylitol study
A. Purpose of study    A3=clear health benefit
B. Probability for     B3=moderate
reaching the
                       C4=sentient, conscious
purpose
                       D3=moderate
C. Species
                       E2=short
D. Anticipated pain
                       F1=very short
E. Duration of pain
                       G2= 5-10
F. Duration of exp
                       H1= excellent
G. Number of
animals
                    C-H= 13, A-H=19
H. Animal care
                       Insuliini ja glukoosi vasteet
                         ksylitolille (1.5 g/kg po)
                 200                                  5
                 180
                 160                                  4




                                                           Glucose (mmol/L)
Insulin (mU/L)




                 140
                 120                                  3
                                                                              Insulin
                 100
                  80                                  2                       Glucose
                  60
                  40                                  1
                  20
                   0                                   0
                       0   100      200       300   400
                                 Time (min)
  A Dutch system to support
      decision-making

In 1999 Frans Stafleu, Ronno Tramper,
Jan Vorstenbosch and Jaap Joles have
developed a system to support decision-
making.
In order to compare the apples with the
oranges they quantified the different
aspects.
  Cost – Means - Benefit principle
Cost                                                        Benefit
                                      Human health
       Pain, distress,                Animal health
       discomfort, suffering          Safety (toxicity studies)
       Duration, frequency,           Increasing knowledge
       severity of those              Ecology
       Death                          Economy (macro)


                         Facilities, transport
                         Training and competence
                         Veterinary care
       Means             Experimental design
                          - species, number
                          - end points
                          - alternatives
                         Animal source
                         Negative results
            Nordic Forum 2003:
           Cost - Benefit - Means

          High



BENEFIT                             Means
                       Purpose        Quality   no and
                                                species

                       Likelihood    Pain       Quality of
                                                care
          Low



                 Low                                High

                       COST
Retro perspective
ethics evaluation?
       Cost benefit primer
Four short study protocols
Read through and discuss in groups
   identify both benefits and costs
   weigh them against each other
   place them on 3 x 3 cells
   consider means to
      increase the benefits
      decrease the costs

				
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